Feliza Mirasol is the science editor for 

Articles

Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.

Sarepta’s Elevidys for Duchenne Muscular Dystrophy Gets Expanded FDA Approval

Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.

CDER Gives Update on New Drugs Regulatory Program

FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.

argenx Gets FDA Nod for VYVGART Hytrulo in CIDP Indication

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Videos

In the premiere episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier. 

Quality Considerations in Changing Excipient Providers

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

The pairing of Abzena and Argonaut Manufacturing Services is the result of several years’ worth of collaborative work between the two companies.

CDMOs Announce Strategic Partnership for Fully Integrated Manufacturing Solutions

This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.

WHO Warns About Falsified Ozempic Batches

A new initiative will advance access to quality medicines and vaccines in Africa.

USP and African Institutions Provide Free Access to Pharma Production Resources

The transaction, announced June 20, follows Bora’s purchase of Minnesota-based Upsher-Smith Laboratories earlier in 2024.

Bora Pharmaceuticals Acquires Baltimore Manufacturing Facility from Emergent

Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.

AstraZeneca mAb Approved by FDA for Endometrial Cancer Patients

The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.

News